Perioperative Rehabilitation in Operation for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maximum oxygen uptake (VO2peak)
研究概览
简要总结
Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.
Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.
Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.
What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.
- Exercise before surgery is a home-based exercise program is individually designed and must be performed for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
- The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program and three individual counseling sessions. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered. The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week.
What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).
Will all participants receive the same treatment?
By draw it is decided which of the 4 groups the participants will attend to in the study:
- Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
- Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
- Group 3: Rehabilitation initiated as early as two weeks after surgery
- Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group) What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance status 0-2 (WHO)
- •Living in the City of Copenhagen or surrounding Municipalities
- •Ability to read and understand Danish
- •Approval by primary surgeon
排除标准
- •Presence of metastatic disease or surgical inoperability
- •Diagnosis of Lung Cancer not verified by histological diagnosis
- •Cardiac disease
结局指标
主要结局
Maximum oxygen uptake (VO2peak)
时间窗: VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
VO2peak is evaluated by an incremental test using an electromagnetically braked cycle ergometer (Lode Corival Ergometer©). Inspired and expired gases are analyzed breath-by-breath by a metabolic cart (JAEGER MasterScreen CPX©). Subjects begin pedaling at seven watts and resistance increases after a predefined 10 watts ramp protocol until exhaustion or a symptom-limited VO2peak is achieved (pain, dizziness, anxiety etc.).
次要结局
- Six minute walk distance (6MWD)(baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.)
- Patient reported outcomes (PROs)(Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.)
- Pulmonary function(Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.)
研究者
Jesper Holst Pedersen
MD, DrMSci
Rigshospitalet, Denmark